Medtronic anticipates the battery life of the Micra AV2 and Micra VR2 to be roughly 16 and 17 years, respectively, with approximately 40% greater battery life than prior models.3 This means that more than 80% of individuals who receive a Micra may only need one device for the rest of their lives.
This CE Mark milestone comes after the Micra AV2 and VR2 devices were approved by the US Food and Drug Administration in 2023.
Micra devices are the only leadless pacemakers with remote monitoring capabilities, allowing a doctor or clinic to check on a patient’s heart device without the patient having to drive to their clinic for an in-person session. Other patient advantages of remote monitoring may include fewer hospitalizations and a greater sense of security.
“For more than eight years, our Micra leadless pacemakers have provided meaningful benefits to people in Europe who require a pacemaker. Now, these patients have access to the latest leadless pacing technology that, for most of them, maybe the only device they will ever need,” said Robert C. Kowal, M.D., Ph.D., general manager, Cardiac Pacing Therapies within the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic.
“The first generation of leadless Micra pacemakers demonstrated a significant reduction in major complications, and this next generation of Micra brings several additional benefits including greater longevity, and specifically for the Micra AV2, new algorithms to optimize AV synchrony at faster heart rates while requiring less in-office programming,” said Prof. Dr. Christophe Garweg, Cardiologist at University Hospitals of Leuven, Belgium. He added further, “These advantages likely will expand the use of the leadless pacemaker to more patients.”
According to DelveInsight’s “Pacemakers Market” report, the global pacemakers market was valued at USD 4.88 billion in 2022, growing at a CAGR of 5.85% during the forecast period from 2023 to 2028, to reach USD 6.84 billion by 2028. The demand for pacemakers is primarily motivated due to the rise in cardiovascular diseases (CVDs), superior treatment outcomes of sudden cardiac arrests, and growing technological advancements among others during the forecast period.
Medline Introduced First-of-its-kind Transparent Wound Dressing Aiding in Pressure Injury Prevention
On January 9, 2024, Medline, the market leader in skin care, announced the newest addition to the company’s sophisticated wound care line The OptiView® Transparent Dressing with HydroCoreTM Technology. This first-of-its-kind wound dressing has a novel clear design that allows caregivers to inspect, monitor, and blanch skin while the covering is in place.
Pressure and excessive heat can cause skin breakdown and raise the risk of pressure injury development. Traditional routine skin assessments necessitate removing the wound dressing numerous times per day, which is exhausting on both the caregiver and the clinician and puts additional strain on the dressing’s adhesive and underlying skin.
OptiView enables caretakers to detect skin texture, color variations, and early indicators of breakdown without lifting the dressing. The revolutionary clear island allows for direct visibility of the underlying skin, while the HydroCore Technology employs a gel center to help redistribute pressure and pull heat away from the skin to generate a cooling effect.
The soft silicone and HydroCore Technology of OptiView make it excellent for protecting and dressing sensitive regions. The multisite 6″x6″ dressing can be used on troublesome locations such as elbows, knees, heels, and shoulders. The 7″x7″ and 9″x9″ dressings are particularly intended for use on the sacrum.
“Medline has a long history of innovation in wound care, with a focus on providing the right tools and expertise to help enhance wound care efficiency. OptiView is an exciting addition to our portfolio, aimed at overcoming healing barriers and elevating care standards,” said AJ Ford, vice president of Medline Skin Health. Ford added, “We are grateful for the product feedback received from nurses nationwide who helped us make impactful changes to ensure OptiView is a successful addition to a care provider’s pressure injury prevention plan.”
“It is time-consuming to keep an eye on wounds under the dressings and our clinical team sometimes assumed that as long as the dressing was on there, the wound would be okay. This led to pressure injuries,” said Holly Baglio, DNP, RN-BC, MSN, CWOCN, BS, Inpatient Wound Ostomy Continence Registered Nurse for UCHealth Highlands Ranch Hospital, a 93-bed hospital. Holly commented, “OptiView has helped us both treat and prevent future pressure injuries, and the longer wear time and less dressing changes have introduced cost savings into our organization. Our nurses can make OptiView last five days, compared to maybe 12 hours from traditional foam dressings.”
According to DelveInsight’s “Wound Healing Devices Market” report, the global wound healing devices market was valued at USD 19,724.65 million in 2022, growing at a CAGR of 5.32% during the forecast period from 2023 to 2028, to reach USD 26,761.38 million by 2028. The increase in demand for wound healing devices is primarily attributed to the shifting focus among the population on lowering healthcare costs, and the rising shift from the traditional techniques of wound care management towards sophisticated wound care techniques and products across the globe.
Moreover, an upsurge in various chronic and acute wounds across the globe, and a rise in the usage of wound healing devices such as dressing products, and wound healing devices among the patient population, among others are also expected to bolster the demand for these services in the upcoming years.
Medtronic Diabetes Announced World’s First Approval for MiniMed™ 780G System with Simplera Sync™ disposable, all-in-one Sensor
On January 8, 2024, Medtronic plc., a global leader in healthcare technology, announced that the MiniMed 780G system with Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM) needing no fingersticks or overtape, received CE (Conformité Européenne) Mark approval. Simplera Sync is half the size of prior Medtronic sensors and provides a better user experience with a simple, two-step insertion technique.
In Europe, the MiniMed 780G system with Simplera Sync sensor will be offered in limited quantities beginning in spring 2024. Throughout the summer of 2024, Medtronic will begin a phased commercial launch throughout Europe. The MiniMed 780G system is now compatible with the Guardian 4 sensor.
The MiniMed 780G insulin delivery system is Medtronic’s most advanced, automatically changing and correcting glucose levels every 5 minutes. It is the world’s only system featuring a Meal Detection feature, which is intended to prevent post-meal hyperglycemia when users forget to take insulin or misjudge the number of carbs in their snacks or dinner. The system, which comes with the world’s only 7-day infusion set, also has one of the lowest glucose target settings of any automated insulin administration system (as low as 100 mg/dL). With this “treat to target” strategy, the system more nearly resembles the glucose levels of someone who does not have diabetes. Fingersticks are not required with either the Simplera Sync sensor or the Guardian 4 sensor.
“We’re incredibly proud that the MiniMed™ 780G system continues to be the most widely used automated insulin delivery system in Europe since we launched it in 2020. Real-world data on over 100,000 users on the system across many geographies and cultures shows that when using recommended settings the system is delivering an average Time in Range of nearly 80%, raising the bar on what ‘good’ looks like2,” said Que Dallara, EVP and President, Medtronic Diabetes. Que added, “With the introduction of Simplera Sync™ sensor, we’re able to offer the proven benefits of our MiniMed™ 780G system with our newest and most comfortable sensor that can be applied in under 10 seconds.”
As per DelveInsight’s “Insulin Delivery Devices Market” report, the global insulin delivery devices market was valued at USD 15.51 billion in 2022, growing at a CAGR of 9.28% during the forecast period from 2023 to 2028, to reach USD 26.35 billion by 2028. The rise in demand for insulin delivery devices is predominantly attributed to the rising prevalence of diabetes among the geriatric population, favorable reimbursement scenarios, rising awareness about proper diabetes management and insulin delivery devices, and technological advancement in the product line, among others.
Biosense Webster Announced Regulatory Approval of VARIPULSE™ Pulsed Field Ablation (PFA) Platform in Japan
On January 9, 2024, Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced that the VARIPULSE Platform has been approved by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the treatment of symptomatic drug-refractory recurrent paroxysmal atrial fibrillation (AFib) using pulsed-field ablation (PFA).
The VARIPULSE Platform is made up of the VARIPULSE Catheter, which is a variable-loop multielectrode catheter; the TRUPULSE Generator, which is a multichannel PFA generator; and the CARTO 3 System, which is the world’s premier 3D cardiac mapping system. The VARIPULSE Platform is the first and only PFA system that is CARTO-integrated, allowing for a straightforward and reproducible process with real-time visualization and feedback mechanisms.
Early clinical data from the inspIRE trial with the VARIPULSE Platform in Europe showed a one-year clinical success rate of 78.9%, defined as independence from recorded symptomatic atrial arrhythmia recurrence. The trial also had an impressive safety profile, with no primary adverse events (0%). Because of the platform’s patented pulse sequence, catheter design, and CARTO 3 System integration, the workflow was streamlined, resulting in less fluoroscopy time (7.8 minutes) and more efficient procedures (70 minutes).
Catheter ablation is a minimally invasive method used by electrophysiologists to treat cardiac rhythm problems such as AFib by blocking irregular electrical pathways in the heart with either heat (radiofrequency ablation) or cold (cryoablation). PFA is a novel technique for treating AFib that employs a regulated electric field to selectively ablate cardiac tissue that produces irregular heartbeats via a process known as irreversible electroporation (IRE). Because the pulsed field energy is not thermal, IRE has the potential to lessen the danger of tissue damage, such as esophageal, pulmonary vein, and phrenic nerve injury.
“The innovation in catheter ablation therapy for atrial fibrillation has been remarkable. The approval of ablation therapy using pulsed-field energy in Japan will further advance the treatment of arrhythmias. Together with the integrated 3D mapping system, this innovation has the potential to provide more advanced treatment and further improve safety,” said Dr. Wataru Shimizu, President of the Japan Heart Rhythm Society (Professor, Department of Cardiovascular Medicine, Graduate School of Medicine, Nippon Medical School). Dr. Wataru commented, “The increasing diversity of treatment technologies means that healthcare providers who seek to cure atrial fibrillation have options tailored to each patient’s condition.”
According to DelveInsight’s “Cardiac Ablation Devices Market” report, the global cardiac ablation devices market was valued at USD 2.25 billion in 2022, growing at a CAGR of 12.77% during the forecast period from 2023 to 2028, to reach USD 4.63 billion by 2028. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Further, growth in new therapies, technological advancements, increasing geriatric population, and penetration and acceptance of cardiac ablation devices in emerging countries will drive market growth.
Rivermark Medical Announced Completion of Expanded Indication Study for the Flostent™ System
On January 8, 2024, Rivermark Medical, a company dedicated to developing a novel therapeutic device for benign prostatic hyperplasia (BPH) reported the successful completion of its RAPID-UR research, an extended indication study performed by Drs. Ingrid Perscky and Ruben Urena at the Pacifica Salud Costa del Este Hospital in Panama City, Panama; examined the use of the company’s FloStent System in patients suffering from urine retention owing to BPH.
Urinary retention (UR) is the inability of a patient to pass urine, which frequently necessitates the implantation of a temporary indwelling catheter for relief. BPH is the most common cause of obstructive UR, which is caused by prostate enlargement, which restricts and obstructs urine flow. Benign Prostatic Hyperplasia causes 53-65% of acute UR cases and individuals who have experienced acute UR have a 56% greater risk of recurrent episodes. There are currently no commercially viable catheter-free device therapies for UR.
Rivermark’s FloStent System is a specially designed nitinol stent that gently supports the prostatic urethra to restore normal urine flow and provide patients with Benign Prostatic Hyperplasia with immediate relief. The technology can be used during outpatient treatment with any flexible cystoscope to provide a therapeutic intervention at the time of diagnosis, with fewer complications and a shorter recovery time.
Rivermark’s clinical program includes recently completing the 12-month follow-up for the RAPID-I first-in-human (FIH) clinical research in Panama City, Panama, in which patients with Benign Prostatic Hyperplasia were treated with the FloStent System. Clinical data from the RAPID-I FIH research, as well as results from the RAPID-UR expanded indication study, will be presented at upcoming Urology conferences.
“Urinary retention can be a painful and severe condition for men with BPH,” stated Adam Kadlec, M.D., Co-Founder and CEO of Rivermark Medical, and practicing Urologist at Aurora Healthcare in Milwaukee, Wisconsin. “Surgery is often recommended, but this is daunting for patients and poses significant risks. A consistently effective, outpatient-based, minimally invasive device option for patients suffering from urinary retention is sorely needed. We are confident this expanded application of the FloStent System will address this critical unmet need.”
According to DelveInsight’s “Benign Prostatic Hyperplasia Devices Market” report, the benign prostatic hyperplasia devices market is expected to grow at a CAGR of 7.02% during the forecast period from 2023 to 2028. The benign prostatic hyperplasia devices market is witnessing growth owing to the increasing incidence of benign prostatic hyperplasia (BPH) across the globe. Further, the growing focus on healthcare, the aging population, a declining lifestyle, unhealthy eating habits, inherited disease, and an increase in research and development activities among others are some of the major factors influencing benign prostatic hyperplasia devices market growth.
Cala Announced Data from Multiple Clinical Studies Demonstrating Effective Outcomes of Transcutaneous Afferent Patterned Stimulation (TAPS) Therapy in Essential Tremor (ET) Patients
On January 9, 2024, Cala, the bioelectronic medicine pioneer, presented the findings of various clinical investigations, adding to the body of evidence confirming excellent outcomes for patients receiving Cala TAPS Therapy in Essential Tremor.
CVS Health discovered that adding Cala TAPS therapy to the standard of care (SOC) increased outcomes above SOC alone in a randomized pragmatic trial. The study recruited patients from a large health insurer’s database (AETNA) and is the largest prospective device study in essential tremor to date (N = 310).
The study discovered significant improvements in tremor power (as evaluated by motion sensors) and Bain & Findley Activities of Daily Living (BF-ADL) upper limb scores after one month of TAPS versus SOC alone, suggesting that TAPS is a safe and effective therapy option for Essential Tremor patients.
The study found A randomized controlled study found significant improvement over sham in the high unmet need subgroup (severe tremor, non-responsive to medication, age 65 years) (N = 47, P 0.03) and significant improvements over multiple months of use in the high unmet need (N = 138, P 0.001) and early responder cohort (N = 51, P 0.001).
“We are excited about the growing body of evidence demonstrating that TAPS improves patient outcomes in real-world settings,” said Kate Rosenbluth, Ph.D., Co-President and Chief Scientific Officer, of Cala Health. Kate added, “With these latest publications, TAPS has now been assessed in nearly 2,000 ET patients and with use extending beyond 3 years. TAPS addresses the large treatment gap between medications and surgery for ET patients struggling with activities of daily living such as eating, drinking writing, and self-care.”
“Cala is a contracted provider with major national and regional health plans for essential tremor including both commercial and Medicare Advantage members,” said Deanna Harshbarger, Co-President and Chief Product Officer, of Cala Health. Deanna mentioned, “The Cala System is covered by the Veterans Affairs (VA) Health System at no cost to VA beneficiaries. With these expanded publications, Cala will continue working tirelessly on behalf of patients with ET to secure additional coverage and reimbursement.”
According to DelveInsight’s “Essential Tremor TreatmentMarket Insights, Competitive Landscape, and, Market Forecast” report, the global essential tremor treatment market is expected to grow at a CAGR of 6.13% during the forecast period from 2023 to 2028. The report comprises important market factors that have a substantial influence on both present and future market trends of essential tremors from an international perspective. The research covers a wide range of global regions, including important players such as the United States, Europe, China, Japan, India, the Middle East, and Africa among others. It provides a holistic perspective of the worldwide market landscape by studying market dynamics and trends across these varied areas, supporting well-informed decision-making and strategic planning for organizations with a global presence in the overall essential tremor treatment market.
